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NEW BRUNSWICK, N.J.,
February 4, 2021 – Johnson & Johnson (NYSE: JNJ) (the
Company) announced that Janssen Biotech, Inc., has submitted an application
to the U.S. Food and Drug Administration (FDA) requesting Emergency Use
Authorization (EUA) for its investigational single-dose Janssen COVID-19
vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3
ENSEMBLE clinical trial, demonstrating that the investigational single-dose
vaccine met all primary and key secondary endpoints. The Company expects to
have product available to ship immediately following authorization.
“Today’s submission
for Emergency Use Authorization of our investigational single-shot COVID-19
vaccine is a pivotal step toward reducing the burden of disease for people
globally and putting an end to the pandemic,” said Paul Stoffels, M.D.,
Vice Chairman of the Executive Committee and Chief Scientific Officer at
Johnson & Johnson. “Upon authorization of our investigational COVID-19
vaccine for emergency use, we are ready to begin shipping. With our
submission to the FDA and our ongoing reviews with other health authorities
around the world, we are working with great urgency to make our
investigational vaccine available to the public as quickly as possible.”
The Company has
initiated rolling submissions with several health agencies outside the
U.S., and will submit a Conditional Marketing Authorisation Application
(cMAA) with the European Medicines Agency in the coming weeks.
Manufacturing and
Supply Chain Information
The Janssen
investigational vaccine is compatible with standard vaccine distribution
channels. If authorized, Janssen’s investigational single-dose vaccine is
estimated to remain stable for two years at -4°F (-20°C), at least three
months of which can be stored in most standard refrigerators at
temperatures of 36°F–46°F (2°-8°C). The Company will ship the vaccine using
the same cold chain technologies it uses today to transport other
innovative medicines.
Janssen’s
Investigational COVID-19 Vaccine
The Janssen
investigational COVID-19 vaccine leverages the Company’s AdVac® vaccine platform, which was also used to develop and
manufacture Janssen’s European Commission-approved Ebola vaccine regimen
and construct its investigational Zika, RSV, and HIV vaccines. The safety
profile observed was consistent with other investigational vaccines using
Janssen’s AdVac® technology among more than 200,000 people to date.
Phase 3 ENSEMBLE
Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind,
placebo-controlled clinical trial in adults 18 years old and older. The
study was designed to evaluate the safety and efficacy of the Janssen
investigational vaccine in protecting against both moderate and severe
COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28
as co-primary endpoints.
The trial, conducted
in eight countries across three continents, includes a diverse and broad
population.
Research and
development activities for the investigational Janssen COVID-19 vaccine
including the ENSEMBLE clinical trial and the delivery of doses for the
U.S. has been funded in whole or in part with federal funds from the U.S.
Department of Health and Human Services, Office of the Assistant Secretary
for Preparedness and Response, Biomedical Advanced Research and Development
Authority (BARDA), under Contract No. HHSO100201700018C, and in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH) at the
U.S. Department of Health and Human Services (HHS).
Janssen has worked
with BARDA since 2015 on innovative solutions for influenza, chemical,
biological, radiation and nuclear threats and emerging infectious diseases
such as Ebola. In February 2020, Janssen and BARDA began work on the
development of a COVID-19 vaccine based on Janssen’s
AdVac® technology.
For more information
on the Company’s multi-pronged approach to helping combat the pandemic,
visit: www.jnj.com/coronavirus.
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About Johnson &
Johnson
At Johnson &
Johnson, we believe good health is the foundation of vibrant lives,
thriving communities and forward progress. That’s why for more than 130
years, we have aimed to keep people well at every age and every stage of
life. Today, as the world’s largest and most broadly-based healthcare
company, we are committed to using our reach and size for good. We strive
to improve access and affordability, create healthier communities, and put
a healthy mind, body and environment within reach of everyone, everywhere.
We are blending our heart, science and ingenuity to profoundly change the
trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen
Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're
creating a future where disease is a thing of the past. We're the
Pharmaceutical Companies of Johnson & Johnson, working tirelessly to
make that future a reality for patients everywhere by fighting sickness
with science, improving access with ingenuity, and healing hopelessness
with heart. We focus on areas of medicine where we can make the biggest
difference: Cardiovascular & Metabolism, Immunology, Infectious
Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Notice to Investors
Concerning Forward-Looking Statements
This press release
contains "forward-looking statements" as defined in the Private
Securities Litigation Reform Act of 1995 regarding development of a
potential preventive vaccine for COVID-19. The reader is cautioned not to
rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize, actual
results could vary materially from the expectations and projections of the
Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and uncertainties
inherent in product research and development, including the uncertainty of
clinical success and of obtaining regulatory approvals; uncertainty of
commercial success; manufacturing difficulties and delays; competition,
including technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in behavior and
spending patterns of purchasers of health care products and services;
changes to applicable laws and regulations, including global health care
reforms; and trends toward health care cost containment. A further list and
descriptions of these risks, uncertainties and other factors can be found
in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year
ended December 29, 2019, including in the sections captioned “Cautionary
Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and
in the company’s most recently filed Quarterly Report on Form 10-Q, and the
company’s subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson
& Johnson. None of the Janssen Pharmaceutical Companies nor Johnson
& Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
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